Conversations with... John E. Tomaszewski, MD

GEORGE LUNDBERG, MD: Hello and welcome. I'm Dr. George Lundberg, Editor-at-Large for MedPage Today, and we are having a conversation with Dr. John Tomaszewski, who is the Professor and Chair of the Department of Pathology and Anatomical Sciences at the State University of New York's School of Medicine and Biomedical Sciences in Buffalo.

He also happens to be the current President of the American Society for Clinical Pathology at which meeting we're currently having this conversation in Las Vegas. So thank you very much for being with us today; we appreciate it.

JOHN TOMASZEWSKI, MD: Thank you very much; a pleasure to be here.

LUNDBERG: I first heard the word molecular pathology from my professor when I was in medical school, and his name was J.F.A. McManus and he was the inventor of the PAS stain, which he'd done on a sabbatical at Oxford. Then he came to Birmingham, Alabama, and he started talking about molecular pathology, and that's a very long time ago.

Then I didn't hear about it at all for a long, long time from anybody, and now, of course, it is the rage. It is the future, the understanding of the inside of cells of all sorts of things -- genetic, genomic, pathways, enzymes, mutations, tests to determine those. And I think that's where you largely work. Am I right?

TOMASZEWSKI: Yes. We have a big focus on what we like to term new diagnostics, 21st century diagnostics, where there is a big focus on the molecular pathways that drive disease -- understanding them, coordinating them with image and structure, and putting them into some sort of integrated idea that allows us to predict very specifically and more precisely a patient's prognosis and a response to therapy.

LUNDBERG: How much of this has to do with cancer, and how much of it has to do with other diseases?

TOMASZEWSKI: There is a big body of knowledge in infectious disease and a growing body of knowledge in cancer. And, of course, genetic testing for, you know, inherited genetic diseases is where a lot of it started back in the '80s and '90s.

LUNDBERG: Well, everybody understands that there's the genetics element, which unfortunately put a lot of doctors to sleep for a long time. You'd have programs on genetics and medicine and nobody would come.

TOMASZEWSKI: Right.

LUNDBERG: But I think that's changed with the molecular elements and with the science being much better at this point and much more applicable to individual patients.

TOMASZEWSKI: Yes. A lot of this is driven by the new therapeutic interventions that, if targeted properly, can have a great effect on a subpopulation of some patients with a given disease. So big interest is driven by the ability to put in a small molecular modifier, know that it's there, modify it, and see a disease change specifically because of that.

LUNDBERG: Now, is the distinction between diseases and between patients with diseases so unique by subtypes, and subtypes of subtypes, that one could say if you've seen one, you've seen one, or are there more global ways to look at it?

TOMASZEWSKI: Both. But the former idea that you enunciated is exactly where things are going. I actually was trained and was at the University of Pennsylvania where Dr. Peter Nowell, you know, discovered the Philadelphia chromosome, and this was a way of identifying a very specific type of leukemia which we've now come to learn has very specific targeted therapies that can modify it.

But Peter's idea was that there was a whole bunch of these in cancer and that we would have to reinvent this idea over and over again, which is exactly what's happening right now. So a lot of it is subset analysis with targeted therapies for subsets of diseases that we understand under a bigger banner.

LUNDBERG: So targeted diagnostics and then targeted therapeutics.

TOMASZEWSKI: Correct.

LUNDBERG: Produced by large numbers of small companies, or produced by the big pharmas who were going to do this kind of creation of drugs rather than the blockbuster big drugs, or what?

TOMASZEWSKI: Yeah, it's an interesting mix. I think right now -- in the purely diagnostic sphere -- there's a lot of small companies that are active; that the concept of companion diagnostics attached to drug development and actually embedded in the process of the clinical trial space is really gaining interest in large pharma. So I think you would have an interesting mixed environment of molecular diagnostics.

LUNDBERG: Now, how important is it going to be in our country, the United States, for a practicing pathologist to help a practicing clinician understand and use correctly the new targeted diagnostics?

TOMASZEWSKI: We're very concerned about good test utilization, because if poorly done it could make things worse, basically.

And so ASCP thinks that the selection of the right tests at the right time for the right patient at the right cost is really the challenge of 21st century diagnostics, and these targeted diagnostics are a big part of that.

LUNDBERG: I'm glad you mentioned cost, because some of these tests are not cheap.

And, of course, they shouldn't be cheap, because the amount of scientific energy and money that had to go into developing them has to be recouped in some kind of a way. And, of course, the targeted therapeutics now sometimes are very expensive.

TOMASZEWSKI: Right.

LUNDBERG: And will have to be dealt with in heartrending -- wrenching ways, shall we say, by the payers.

TOMASZEWSKI: The cost of these diagnostics has to be looked at in the context of the cost of the entire therapy. If you have a test that costs you a thousand dollars, however, you avoid, you know, the misutilization of the $100,000 drug; you've won. And so we think of things in sort of a global service-line way rather than on an individual per-click way.

LUNDBERG: Well, I think you -- obviously, one has to look at it in that regard and then hold on, because we're off on quite a significant ride. And we haven't mentioned quality control of the laboratories doing these and how a physician and a patient can be confident that a particular lab is doing good work.

TOMASZEWSKI: That is probably the single biggest challenge to the propagation of molecular diagnostics, and let me just sort of be a little bit more specific. Large genome sequencing would be a good example of that. The development of reference databases on which to interpret things and normalize things is a huge challenge for everybody, and then the proficiency testing to know what the inter-lab variation is, is a big, big issue.

LUNDBERG: I think I'll use the word "challenge" that you just used as a good ending for here.

Thank you very much, Dr. John Tomaszewski of Buffalo, New York, and thank you very much for tuning in to our little conversation. I'm Dr. George Lundberg, Editor-at-Large for MedPage Today, signing off.

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